Safety and Efficacy of Newly Developed Knee Prosthesis for Knee Arthroplasty: a Prospective, Single-center, Randomized, Positive Parallel Controlled, Non-inferiority Clinical Trial

Background Total knee arthroplasty is one of major means in the treatment of end-stage knee disease. Therefore, there is an urgent need to develop a safe, effective, high-quality and inexpensive knee prosthesis so as to meet the huge demand for replacement repair in patients with knee diseases in China.

Combined with international advanced design concept, Wuhan Yijiabao Biomaterial Co., Ltd. of China has developed a new set of knee prosthesis system with cobalt-chromium-molybdenum alloy and high cross-linked polyethylene as the main materials. This knee prosthesis system contains femoral condyle, meniscus, tibial tray, and patella. This system uses cobalt-chrome-molybdenum and high cross-linked polyethylene as the active friction interface, which has excellent wear resistance, and provides an ideal treatment for patients with knee diseases. The difference in the efficacy and safety between widely used knee prosthesis and this newly developed knee prosthesis after total knee arthroplasty deserves further verification by randomized controlled clinical trial.

Data collection, management, analysis, and open access

• Data collection: The researchers will fill out a papery case report form for each case. The case report form will be truthfully and carefully recorded in detailed to ensure that the case report form is complete, authentic and reliable.
• Data management: The entire experiment will strictly enforce quality management specification for clinical trials. All papery case report form records will be complete, true, clear and objective. All data will be input to the computer, locked and stored. The completed case report form will be reviewed by the inspector. The first page of the case report form will be handed over to the data manager for data entry and management. From then on, the contents of the case report form will not be altered.
• Data analysis: After the test plan has been determined, the statisticians will be responsible for consultation with the major researchers and formulate a statistical analysis plan. All data will be analyzed using SAS9.3 software. Statistical analysis includes actual number of participants in the two groups, the conditions of dropped-out and eliminated cases, demographic and other baseline characteristics, efficacy analysis, and safety analysis. Besides the statistical methods listed below, detailed and additional exploratory analyses may be necessary, and may be identified in the study report and analysis plan.
• Data open access: If the researchers want to publish or disclose the results obtained from the products of this clinical trial, they must have the prior written consent of the sponsor. The sponsor will review and reply the contents of the proposed disclosure within 30 working days. Without the consent of the researchers, the sponsor will not use the name of the researcher in the advertising of the test equipment. However, in the case of a clinical trial of the test instrument and the submission of a production license to the China Food and Drug Administration, the sponsor can, without the consent of the researchers, directly use all the results obtained from the clinical trial.

Quality control The researchers will strictly comply with the state regulations on the clinical trials of medical devices and the relevant operating procedures. Institutional and personnel requirements: The research center must obtain the qualification of the national clinical drug testing institution in orthopedics. Before the trial, the related personnels will be trained, including clinical protocols, informed procedures, equipment use, and file filling. During the trial, the researchers and test-related personnels will receive targeted training according to the clinical situation.